Replies to post #267702 on Amarin Corp Plc (AMRN)

[MontanaState83]

Nick,

Others on the board raised the issue of whether Reduce It exclusivity granted by the FDA would prevent generic launch into Marine indication. Whether or not that is true, I don't know. I was just expressing that, if true, it would seem odd if AMRN was not aware. If they are, why didn't JT state as such on the call last week.

I hope you are well. Hang in there!!

[sts66]

Am I not thinking right?

Yes.

Does the medicinal and scientific "ruler of the US" (the FDA) not carry the final say-so in this matter?

No - FDA is not in the business of deciding whether patents are valid, or which ones will or could be infringed if they approve a generic, that's up to the courts. Everybody who is thinking the FDA could or would somehow reject or delay ANDAs in order to benefit AMRN to make this debacle "more fair" is barking up the wrong tree. Whether the FDA starts looking closer at the ANDAs now that AMRN lost in court or continues to dawdle because of the appeal I have no idea, but JT wouldn't be talking about injunctions and at-risk launches if he thought the FDA was going to just sit on it's hands until the appeal is decided. That said, with the news that AMRN's API suppliers were approached by generics and were rebuffed, I don't think a generic is actually going to be able to produce GV caps for the FDA to analyze anytime soon, and if generics cannot produce GV the FDA can't advance their ANDAs, so FDA will essentially just sit on it's hands, but not because they made a conscious decision to do so.